Novocure (NASDAQ: NVCR) is one of the biggest gainers on Wall Street on Tuesday after the company provided an update on its phase 3 LUNAR trial of Tumor Treating Field in stage 4 non-small cell lung cancer.
Novocure’s share price is trading 55% higher at $205.62 at the time of writing after rallying over 72% premarket.
Source: IG
Following a routine review of the study by an independent data monitoring committee (DMC), Novocure was informed that the pre-specified interim analysis for the LUNAR trial would be accelerated given the length of accrual and the number of events observed to date.
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After reviewing the interim analysis report, the DMC concluded that the LUNAR trial should continue with no evidence of increased systemic toxicity, the company said.
Novocure said it has notified the FDA of the DMC recommendations and intends to submit an Investigational Device Exemption (IDE) supplement incorporating the recommended protocol adjustments.
“The completion of the LUNAR interim analysis is an important milestone for Novocure,” said Asaf Danziger, Novocure’s CEO.
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“We are grateful to the DMC members for their diligence, guidance and support, and are looking forward to working closely with the FDA on amendments to the protocol given the DMC’s recommendations. Pending regulatory approval, the recommended protocol adjustments could accelerate trial completion by more than a year. We look forward to sharing final data from the LUNAR trial as quickly as possible,” added Danziger.
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